Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)

NCT02483429 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: IRB000442281U01DC013778-01A1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 5

Brief Summary

AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to standard care to assess accuracy of diagnoses and initial management decisions for emergency department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of vestibular cause. The trial will test the hypothesis that VOG-guided rapid triage (VRT) will accurately, safely, and efficiently differentiate peripheral from central vestibular disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the potential to improve post-treatment clinical outcomes for these patients.

Conditions

Vertigo; Dizziness

Keywords

Vertigo; Dizziness; Unsteadiness; Stroke; Vestibular neuritis; Benign paroxysmal positional vertigo; Vestibulo-ocular reflex; Video-oculography; Emergency department

Outcome Measures

Primary Outcomes (3)

• VRT vs. ED SOC Six-Category Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison)

  Total diagnosis accuracy VRT vs. ED SOC using 30-day adjudicated final diagnoses categorized in one of six diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). VRT diagnoses were based on automated interpretation of ED index VOG tests in the context of structured medical history information and examination findings from the ED index visit (clinically supervised for safety), while ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations. Final diagnoses were based on ED index visit, 1-week, and 30-day follow-up clinical assessments. The population was limited to those with complete 1-week follow-up testing including in-person vestibular specialist exam, repeat VOG assessment, and MRI with diffusion-weighted images for ischemic stroke detection.

  30-day follow-up time point

• VRT vs. ED SOC Total Diagnostic Utilization Costs at the ED Index Visit (Primary Analysis-eligible Participants, Two-arm Comparison)

  Total US dollar costs VRT vs. ED SOC for diagnostic tests and consultations obtained during the ED index visit and associated hospital admission (for those admitted at the index visit). For the VRT arm, this does not include costs of safety MRIs required by the institutional review board (IRB)-approved protocol or any tests ordered "off protocol" by ED physicians (i.e., it represents VRT-recommended utilization-based costs); however, it does include tests, consultations, or admissions ordered "on protocol" by consultants or ED physicians in the VRT "equivocal" diagnosis pathway. For the SOC arm, this includes all utilization-related costs from the ED index visit (tests, consultations, or admissions). Total costs are calculated by multiplying fixed cost estimates (2025 national average Medicare reimbursement in US dollars) by utilization rates for each ED index visit service tracked.

  30-day follow-up time point

• Participants With Short-Term Prespecified Medical Event(s) of Interest (PMEIs) After a Correct vs. Incorrect Diagnosis (Primary Analysis-eligible Participants, One-arm Comparison [SOC Arm Only])

  PMEIs included ED revisits, falls, vascular events, and test or treatment complications. PMEIs occurring between the ED index visit disposition and 1-week follow-up visit (after which the two arms joined the same diagnostic pathway) were considered. Events diagnosed at ED index visit were not counted. Events newly diagnosed at 1-week follow-up or in the interval prior to 1-week follow-up were counted, regardless of relatedness to ED index dizziness symptoms, with the exception of test or treatment complications, which were required to be related directly or indirectly to the dizziness symptoms. To avoid "double counting" misdiagnoses as follow-on PMEIs pursuant to an initial misdiagnosis, 1-week stroke diagnoses not rendered at the ED index visit were not counted unless neurologic or vestibular symptoms/signs worsened after the ED index visit. Six-category accuracy was used to determine "correct" vs. "incorrect" index ED SOC diagnoses relative to 30-day adjudicated final diagnoses.

  1-week follow-up time point

Secondary Outcomes (2)

• Expert VOG vs. ED SOC Six-Category Diagnosis Accuracy (Participants With a Known Final Diagnosis, One-arm Comparison [SOC Arm Only])

  30-day follow-up time point

• VRT vs. ED SOC Stroke-No Stroke Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison)

  30-day follow-up time point

Study Arms (2)

VRT Care

EXPERIMENTAL

Patients randomized to VRT (VOG-guided Rapid Triage) care will have an algorithm-determined patient-specific diagnosis and treatment pathway in the emergency department. Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up.

Device: VRT Care

Standard of Care (SOC)

NO INTERVENTION

Patients randomized to Standard of Care will undergo usual emergency department care without revealing results of VOG testing. Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up.

Interventions

VRT Care DEVICE

The VOG report includes direct device output (physiologic traces, quantitative measures) plus most likely diagnosis, category, and clinical trial care pathway (peripheral, equivocal, central) instructions. The VOG report becomes part of the patient's emergency department clinical record.

Also known as: GN Otometrics (Instrumentation & Control Systems, Inc)

VRT Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years and older) ED patients with all of the following (all determined pre-randomization):
• VESTIBULAR SYMPTOMS: presenting symptom of "vertigo" OR "dizziness" OR "unsteadiness" (as defined by consensus expert definitions in the International Classification of Vestibular Disorders).
• RELEVANT EXAM SIGNS\*: pathologic nystagmus (spontaneous, gaze-evoked, or positional) by bedside VOG testing OR pathologic ataxia (gait, trunk, stance, limbs) by bedside ataxia examination.
• RECENT ONSET: symptoms AND signs\* appear to be new or markedly worse in the past month. (\*Exam signs are required for randomization, but not for the observational arm)

You may not qualify if:

• Excluded from Pre-Randomization Screening
• Level 1 trauma or critical illness
• Altered mental status (e.g., delirium, dementia) that would preclude active study participation (this includes patients with abnormal mental state due to alcohol intoxication or illicit substance, which are known, easily-recognized causes of dizziness or vertigo presentations to the ED)
• Non-English speaking (enrollment of non-English speakers is not feasible given the logistics of identifying a translator and the need for rapid recruitment and randomization in the AVERT study; furthermore, the terms vertigo, dizziness, and unsteadiness may have different meanings in other languages)
• Known pregnancy (all women of childbearing age who are enrolled will undergo a urine or serum beta human chorionic gonadotropin \[hCG\] pregnancy test prior to MRI to confirm no pregnancy, per local institutional guidelines)
• Unable or unsafe to participate in screening, including VOG tests (as deemed by specific pre-enrollment risk assessment questions or ED provider and/or Study Coordinator judgment) including, but not limited to:
• visual impairment sufficient to prevent visual fixation during the VOG testing
• clinically-perceived risk to patient of participating in study (ED provider or staff concerns)
• clinically-perceived risk to research staff (e.g., violence, blood/body fluid/respiratory precautions)
• unstable cardiac status (given a single reported case of bradycardia with impulse testing)
• acute cranio-cervical trauma or other condition (e.g., rheumatoid arthritis) that might lead to instability of the cervical spine that would be a contraindication to neck rotation during VOG testing
• Obvious general medical cause (as judged by treating ED provider) including, but not limited to, acute myocardial infarction, pulmonary embolus, pneumonia, urinary tract infection, drug intoxication, etc.
• Excluded from Randomization (Eligible for Observational Arm Follow-up)
• Patient previously randomized in the AVERT Trial (previously screened but not randomized are eligible)
• Unable to participate fully with study follow-up (particularly MRI) including, but not limited to:

Sponsors & Collaborators

• GN Otometrics: collaborator
• Johns Hopkins University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (5)

University of Illinois

Peoria, Illinois, 61656, United States

Location

Johns Hopkins Hospital - Bayview

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (2)

• Edlow JA, Carpenter C, Akhter M, Khoujah D, Marcolini E, Meurer WJ, Morrill D, Naples JG, Ohle R, Omron R, Sharif S, Siket M, Upadhye S, E Silva LOJ, Sundberg E, Tartt K, Vanni S, Newman-Toker DE, Bellolio F. Guidelines for reasonable and appropriate care in the emergency department 3 (GRACE-3): Acute dizziness and vertigo in the emergency department. Acad Emerg Med. 2023 May;30(5):442-486. doi: 10.1111/acem.14728.

  PMID: 37166022 DERIVED

• Kotwal S, Fanai M, Fu W, Wang Z, Bery AK, Omron R, Tevzadze N, Gold D, Garibaldi BT, Wright SM, Newman-Toker DE. Real-world virtual patient simulation to improve diagnostic performance through deliberate practice: a prospective quasi-experimental study. Diagnosis (Berl). 2021 Mar 8;8(4):489-496. doi: 10.1515/dx-2020-0127. Print 2021 Nov 25.

  PMID: 33675203 DERIVED

Related Links

• Brain Injury OutcomeS (BIOS) website

MeSH Terms

Conditions

Vertigo; Dizziness; Stroke; Vestibular Neuronitis; Benign Paroxysmal Positional Vertigo; Emergencies

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Cranial Nerve Diseases; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: David E. Newman-Toker
• Organization: Johns Hopkins University

toker@jhu.edu

443-287-9593

Study Officials

• David Newman-Toker, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: June 29, 2015
• Study Start: December 4, 2017
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: December 26, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-12

Locations

US (5)